FDA Issues Warning Letter to Indian CDMO Brassica for Data Falsification and Poor Hygiene Practices

1. Warning Letter Issued: The FDA issued a warning letter to Brassica Pharma Pvt. Ltd., an Indian contract development and manufacturing organization (CDMO), on July 11, 2024, citing significant violations of Current Good Manufacturing Practice (CGMP) regulations.
2. Data Falsification: The FDA found that employees at Brassica Pharma routinely falsified data records, including sterility test records and environmental monitoring results.
3. Poor Hygiene Practices: Inspectors observed poor practices and behaviors in ISO 5 and ISO 7 areas, including inadequate cleaning of aseptic processing equipment.
4. CGMP Violations: The FDA identified multiple violations, including failure to ensure complete laboratory records, failure to test every batch for sterility, and failure to collect samples for environmental and personnel monitoring.
5. Consequences: The FDA may withhold approval of new applications or supplements listing Brassica Pharma as a drug manufacturer until the violations are completely addressed and compliance with CGMP is confirmed.